ISMRM23 - Clinical Trials Demystified: Who Are All the Stakeholders When MRI Is Used?

ISMRM & ISMRT Annual Meeting & Exhibition • 03-08 June 2023 • Toronto, ON, Canada

Clinical Trials Demystified: Who Are All the Stakeholders When MRI Is Used?

Member-Initiated Symposium

Monday, 05 June 2023

716A/B

13:45 - 15:45

Moderators: Laura Bell & Samantha By

Session Number: MIST-01

No CME/CE Credit

Organizers: Laura Bell & Samantha By

Overview:
This MIS application is endorsed by the MR in Drug Development study group.

MRI can play a critical role in drug development, spanning the entire process from discovery and development to the preclinical and clinical setting. In the early preclinical phase, MRI can be used to understand disease phenotypes, pharmacokinetics, and pharmacodynamics (i.e. mechanisms of action and dosage). In early-phase clinical trials, MRI can be used as endpoints for safety and efficacy. As clinical trials progress into later phases, MRI can further be used for patient stratification and post-approval research and monitoring. In any case, MRI can be instrumental in assisting the go/no go decision of drug development.

Designing and implementing a clinical trial requires careful collaboration between many different partners.

This symposium intends to highlight various roles of MRI in clinical trials from the perspective of various key stakeholders (pharmaceutical companies, contract research organizations, consortiums, regulatory agencies, investigators, and technologists).

The goal of this program is to provide an understanding of how MR imaging biomarkers can be used in the context of drug development and to provide considerations on how novel MR imaging techniques can be adopted for clinical translation.

This MIS will consist of six 15-minute talks, each followed by a 5-min Q&A.

Target Audience:
Researchers and clinicians (trainees, early career and established) who are interested in learning what is involved in a clinical trial.

As a result of attending this course, participants should be able to:
- Explain the roles of different stakeholders in a clinical trial;
- Describe how to translate new technology into a clinical trial;
- Identify how MR imaging plays a role in drug development; and
- Enumerate the requirements in operationally and scientifically running a multi-site trial.

13:45		The Role of Imaging in Clinical Trials: Proof of Concept to Primary Endpoint Marius de Groot
14:05		Multi-Center Clinical Imaging Trials: Striking a Balance Between Fidelity & Feasibility Iris Friedli Antaros
14:25		Imaging Consortia: Pooling Resources & Sharing the Risks for Validation of Imaging Endpoints Alexandre Fernandez Coimbra Genentech
14:45		Regulatory Perspectives on Clinical Trials with Imaging: Considerations for Incorporating New Technology Jana Delfino FDA
15:05		The Value of Radiographers & Technologists Through Conception, Design, Execution & Publishing of MR Drug Trials Rhys Slough University of Cumbria
15:25		MRI Measures of Disease Activity in MS: Use in Clinical Trials & Translation to Clinical Practice Jiwon Oh Unity Health Toronto